Serum Insulin Response After Acute and Chronic Sucralose Ingestion in Healthy Volunteers With Variable Body Mass Index

NCT03703141 | Completed

• 1 other identifier: 261575
• Study Type: interventional
• Target: 95
• Locations: 0 countries
• Sites: N/A

Brief Summary

The consumption of non-caloric sweeteners has increased worldwide; Current publications suggest its consumption associates to insulin resistance. The present study aims to demonstrate whether acute or chronic sucralose exposure affects insulin or carbohydrate metabolism or alters systemic inflammatory markers and microbiota in young, healthy adults. In this prospective, randomized, double-blind, placebo-controlled clinical trial, three groups will be included with 30 healthy volunteers each. Group A will receive sucralose 48 mg/ day, group B 96 mg/day and group C plain water as placebo. Subjects will be exposed to acute (one day) and chronic (seventy days) oral sucralose ingestion. After acute or chronic exposure, volunteers will undergo into an Oral Glucose Tolerance Test (OGTT), taking blood samples at -15, 0, 15, 30, 45, 60, 75, 90, 105, 120 and 180 minutes, respectively. Areas under the curve (AUC) for insulin and glucose, will be calculated from zero to one hundred and eighty minutes as described; for C peptide, glucagon, GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide) measure points will be at 0, 30 and 60 minutes only. Differences between one and seventy days AUC means will be compared between the three groups, adjusting for BMI. Besides, initial and final systemic inflammatory markers and inflammatory monocytes levels will be quantified and compare between acute and chronic exposure. Also, a comparison between the percentage of acute and chronic microbiome bacterial population in feces will be made.

Conditions

Healthy

Keywords

sucralose; insulin; AUC; young; inflammatory markers; intolerance

Outcome Measures

Primary Outcomes (1)

• Serum insulin levels

  To assess the effect of acute and chronic exposure to different sucralose concentrations differentiating the area under the curve levels in healthy, young volunteers, at a glucose tolerance test of 180 minutes.

  Change the baseline serum insulin levels at 10 weeks sucralose consumption.

Secondary Outcomes (14)

• C-peptide serum levels.

  Change the baseline serum insulin levels at 10 weeks sucralose consumption.

• Glucose-dependent insulinotropic polypeptide serum levels.

  Change the baseline serum glucose-dependent insulinotropic polypeptide levels at 10 weeks sucralose consumption.

• Glucagon serum levels

  Change the baseline serum glucagon levels at 10 weeks sucralose consumption.

• Glucagon-like peptide-1 serum levels

  Change the baseline serum systemic inflammatory response levels at 10 weeks sucralose consumption.

• Systemic inflammatory response (pCr, Tumor Necrosis Factor , Internferon -, IL-1, IL-6, IL-12, IL-17, e IL-23 serum levels)

  Change the baseline serum systemic inflammatory response levels at 10 weeks sucralose consumption.

Study Arms (3)

Sucralose 48 mg

EXPERIMENTAL

Sucralose 48 mg in 60 ml of water O.D. for ten weeks

Dietary Supplement: sucralose 48 mg (splenda)/day for ten weeks

Sucralose 96 mg

EXPERIMENTAL

sucralose 96 mg in 60 ml of water O.D. for ten weeks

Dietary Supplement: sucralose 48 mg (splenda)/day for ten weeks

Placebo

PLACEBO COMPARATOR

60 ml of water as placebo O.D. for ten weeks

Dietary Supplement: sucralose 48 mg (splenda)/day for ten weeks

Interventions

sucralose 48 mg (splenda)/day for ten weeks DIETARY_SUPPLEMENT

volunteers will take sucralose or placebo daily for 70 days

Also known as: sucralose 96 mg (splenda)/day for ten weeks, placebo

Placebo; Sucralose 48 mg; Sucralose 96 mg

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Men or women
• Ages between 18 and 35 years
• Must not have suffered chronic noncommunicable or infectious diseases
• Must have been practicing light-moderate physical activity before the study
• Normal insulin resistance index according to a homeostatic model value of insulin resistance (HOMA-IR) ≤ 3.8
• Must not be smokers
• They must accept not to consume industrialized foods that contain non-caloric sweeteners during their participation in the study and be agree to receive weekly telephone reminders during the protocol
• Must accept not to consume industrialized beverages containing non-caloric sweeteners during their participation in the study
• Do not consume alcoholic beverages during their participation in the study, do not have alcoholism history and have not consumed alcoholic beverages for less than two weeks before entering to the protocol
• Must have Mexican ancestry
• The volunteers, their parents and grandparents must be from Mexico city metropolitan area
• They must sign the letter of inform consent, expressing their desire to participate as volunteers in the study

You may not qualify if:

• People who have any kind of serious illness at the time of the selection
• People who have been diagnosed with Diabetes Mellitus type 1 or type 2
• People who have been diagnosed with thyroid disease
• People who have been diagnosed with any adrenal glands disease
• People who have been diagnosed with insulinoma
• People who have been diagnosed with malabsorption syndrome
• People with short bowel history
• People who have been diagnosed with HIV
• People who have been diagnosed with any type of neoplasia
• People who have been diagnosed with acute or chronic liver disease
• People who have been diagnosed with kidney disease with compromise on serum glucose levels
• People who have been prescribed with corticosteroid in the last 3 months before entering to the study
• People who have been prescribed with any type of antibiotic, 4 weeks prior to entering to the protocol
• People who have been prescribed with any type of non-steroidal anti-inflammatory, 4 weeks prior to entering the protocol
• People who do not accept to remain in the Clinical Pharmacology Unit during the required time to carry out the oral glucose tolerance curves (4 hours, plus the preparation time)

Sponsors & Collaborators

• Hospital General de México Dr. Eduardo Liceaga: lead

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Related Links

• FDA. Food Additives \& Ingredients. 2015

MeSH Terms

Conditions

Insulin Resistance

Interventions

trichlorosucrose

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Guillermo Melendez, MD, MSc

  Hospital General de Mexico Eduardo Liceaga

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SCREENING
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Projects record and follow-up chief

Study Record Dates

• First Submitted: July 12, 2018
• First Posted: October 11, 2018
• Study Start: September 27, 2016
• Primary Completion: June 4, 2018
• Study Completion: June 4, 2018
• Last Updated: October 11, 2018

Record last verified: 2018-10